DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - Generic Drug Details
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What are the generic sources for dapagliflozin; metformin hydrochloride and what is the scope of freedom to operate?
Dapagliflozin; metformin hydrochloride
is the generic ingredient in two branded drugs marketed by Astrazeneca Ab and is included in two NDAs. There are eleven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Dapagliflozin; metformin hydrochloride has two hundred and thirty-six patent family members in forty-six countries.
Two suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
International Patents: | 236 |
US Patents: | 11 |
Tradenames: | 2 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Clinical Trials: | 102 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE |
DailyMed Link: | DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Generic Entry Date for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET, EXTENDED RELEASE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Eli Lilly and Company | Phase 3 |
Institute of Liver and Biliary Sciences, India | N/A |
Ain Shams University | Phase 1/Phase 2 |
See all DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE clinical trials
Generic filers with tentative approvals for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 10MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 10MG;500MG | TABLET, EXTENDED RELEASE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 5MG;1GM | TABLET, EXTENDED RELEASE;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Class | Biguanide Sodium-Glucose Cotransporter 2 Inhibitor |
Mechanism of Action | Sodium-Glucose Transporter 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
XIGDUO XR | Extended-release Tablets | dapagliflozin; metformin hydrochloride | 2.5 mg/1000 mg | 205649 | 1 | 2018-10-29 |
XIGDUO XR | Extended-release Tablets | dapagliflozin; metformin hydrochloride | 5 mg/500 mg 5 mg/1000 mg 10 mg/500 mg 10 mg/1000 mg | 205649 | 10 | 2018-01-08 |
US Patents and Regulatory Information for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Expired US Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
International Patents for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Montenegro | P13008 | C-ARIL GLUKOZID SGLT2 INHIBITORI i POSTUPAK ZA NJIHOVU UPOTREBU (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD) | ⤷ Sign Up |
Brazil | 112012011726 | comprimidos de duas camadas, seu uso, e suas combinações farmacêuticas | ⤷ Sign Up |
Mexico | PA04011371 | C-ARIL-GLUCOSIDOS COMO INHIBIDORES DE SGLT2 Y METODO. (C-ARYL GLUCOSIDE SGLT2 INHIBITORS AND METHOD.) | ⤷ Sign Up |
South Korea | 101021752 | ⤷ Sign Up | |
Philippines | 12000002657 | C-aryl glucoside SGLT2 inhibitors | ⤷ Sign Up |
Japan | 2018172418 | 二層錠製剤 (BILAYER TABLET FORMULATIONS) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1506211 | 1390017-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN OCH FARMACEUTISKT GODTAGBARA SALTER DAERAV; REG. NO/DATE: EU/1/12/795/001 20121112 |
2498758 | 2090013-0 | Sweden | ⤷ Sign Up | PRODUCT NAME: A COMBINATION OF METFORMIN HYDROCHLORIDE, SAXAGLIPTIN OR A PHARMACEUTICALLY ACCEPABLE SALT THEREOF, AND DAPAGLIFLOZIN OR PH ARMACEUTICALLY ACCEPTABLE SOLVATE THEREOF; REG. NO/DATE: EU/1/19/1401 20191113 |
2498758 | CA 2020 00017 | Denmark | ⤷ Sign Up | PRODUCT NAME: METFORMIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; SAXAGLIPTIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; DAPAGLIFLOZIN ELLER ET FARMACEUTISK ACCEPTABELT SOLVAT DERAF; REG. NO/DATE: EU/1/19/1401 20191113 |
2498758 | PA2020003,C2498758 | Lithuania | ⤷ Sign Up | PRODUCT NAME: METFORMINO HIDROCHLORIDAS; SAKSAGLIPTINAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; DAPAGLIFLOZINAS ARBA FARMACINIU POZIURIU PRIIMTINAS JO SOLVATAS; REGISTRATION NO/DATE: EU/1/19/1401 20191111 |
1506211 | SPC/GB13/021 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: DAPAGLIFLOZIN AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/12/795/001 20121114; UK EU/1/12/795/002 20121114; UK EU/1/12/795/003 20121114; UK EU/1/12/795/004 20121114; UK EU/1/12/795/005 20121114; UK EU/1/12/795/006 20121114; UK EU/1/12/795/007 20121114; UK EU/1/12/795/008 20121114; UK EU/1/12/795/009 20121114; UK EU/1/12/795/010 20121114 |
1506211 | 2014C/041 | Belgium | ⤷ Sign Up | PRODUCT NAME: LA COMBINAISON DE DAPAGLIFLOZINE (OU SON SEL PHARMACEUTIQUEMENT ACCEPTABLE); AUTHORISATION NUMBER AND DATE: EU/1/13/900 20140121 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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